Application for Monitoring and Evaluation of Raynaud's Phenomenon (RaynaudMoni)

December 5, 2023 updated by: University Hospital, Grenoble

Development of an Application for the Monitoring and Evaluation of Raynaud's Phenomenon

To evaluate the feasibility of using a smartphone application for monitoring and evaluation of Raynaud's Phenomenon.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be selected in conjunction with a scheduled consultation in the Vascular Medicine Department or at the Clinical Research Center

Description

Inclusion Criteria:

  • primary or secondary Raynaud phenomenon clinically diagnosed by a physician
  • Phone compatible with the application (most Android smartphones)
  • Non-opposition of participation in the study
  • Affiliation to the social security scheme or beneficiary of such a scheme

Exclusion Criteria:

  • Subject under administrative or judicial supervision
  • Subject not speaking and not understanding French

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Raynaud phenomenon
Use of smartphone application
Other: Smartphone application
use of smartphone application during 2 weeks to 3 months to collect frequency and duration of crises, RCS, photography of finger.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction assessed by a 5-points Likert scales about using the application for the monitoring and evaluation of Raynaud's Phenomenon
Time Frame: 2 weeks
The questionnaire assesses different items such as the ease of use of the application, the installation process on the smartphone, the use of reminders, etc. Overall satisfaction will be calculated as the non-weighted average of all items.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between cutaneous digital temperature assessed by thermography and the severity of Raynaud's Phenomenon
Time Frame: 2 weeks
Correlation between digital temperature and Raynaud's Condition Score (RCS)
2 weeks
Relationship between cutaneous digital temperature assessed by thermography and the frequency of RP attacks
Time Frame: 2 weeks
Correlation between digital temperature and the daily frequency of attacks
2 weeks
Relationship between cutaneous digital temperature assessed by thermography and the duration of RP attacks
Time Frame: 2 weeks
Correlation between digital temperature and the cumulative daily duration of attacks
2 weeks
Relationship between cutaneous digital temperature assessed by thermography and pain during RP attacks
Time Frame: 2 weeks
Correlation between digital temperature and pain during attacks (assessed through a 10-point VAS)
2 weeks
Effect of Raynaud etiology on thermographic data
Time Frame: 2 weeks
Comparison of cutaneous digital temperature between patients with primary and secondary Raynaud
2 weeks
Effect of Raynaud treatment on thermographic data
Time Frame: 2 weeks
Comparison of cutaneous digital temperature between patients treated with calcium channel blockers and untreated patients
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Matthieu Roustit, PharmD, PhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2020

Primary Completion (Actual)

March 30, 2021

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

May 24, 2019

First Submitted That Met QC Criteria

June 11, 2019

First Posted (Actual)

June 13, 2019

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC19.099
  • 2019-A00987-50 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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